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Performs pharmacovigilance activities for all assigned projects or products including
identifying and analyzing safety signals based on a comprehensive evaluation of postmarketing
data and Serious Adverse Events (SAEs) from clinical trials.
Major Activities (Describe main activities)
1. Monitors the clinical safety of projects/products and responds appropriately
2. Performs medical assessment and related activities for single cases, including collecting additional
follow-up information as necessary, medical evaluation of quality defects, review of line
listings of single cases, and preparation of investigator notifications.
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